- Thursday 4th - Friday 5th September 2025
- Hilton London Kensington, London, UK
15th Biosimilars & Biologics World Congress 2025 Europe
The Evolution of Biologics & Biosimilars: Reducing Costs and Improving Accessibility
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15TH BIOSIMILARS & BIOLOGICSCONGRESS 2025 EUROPE
The Evolution of Biologics & Biosimilars: Reducing Costs and Improving Accessibility
We are delighted to invite you to our 15th Biosimilars & Biologics Global Congress 2025. This annual event serves as a premier forum, bringing together influential individuals and pioneering thinkers from the biosimilar and pharmaceutical sectors. Our attendees include industry leaders, policy makers, regulatory experts, patient advocates, and healthcare professionals, all dedicated to expanding patient access and promoting the progress of biosimilar & biologic medicines within the wider healthcare frame work.
The growing importance of biological therapies is clear, offering significant health benefits while also posing considerable challenges related to healthcare funding, organizational frameworks, infrastructure, and global supply networks. Recognizing these evolving dynamics, effective biosimilar policies have become essential, delivering substantial value to the entire healthcare community by enabling broader access to these critical treatments.
This year’s Congress is structured as an engaging platform for comprehensive discussions on the most significant issues influencing the future of biosimilars. We will explore vital topics such as improving patient access to biotherapies, encouraging robust market competition, understanding the newest developments in regulatory science, and examining the transformative impact of biosimilar medicines on healthcare systems and the supporting industrial landscape.
We believe that the 15th Biosimilars and Biologics Global Congress 2025 will offer a valuable opportunity for knowledge acquisition, professional networking, and collaborative solutions. We eagerly anticipate your active participation in these crucial discussions, which will undoubtedly contribute to the ongoing advancement of biosimilar & biologic medicines and better outcomes for patients.
We look forward to meeting you at the Congress!
Sincerely yours,
Jocelyn Raguindin
Conference Director
Facilitate Live
GAIN LATEST INSIGHTS ON:
- Focusing on achieving a balanced regulatory environment and fostering healthy market competition within the biosimilar space.
- Addressing the critical interplay between short-term market dynamics and longer- term healthcare objectives.
- Key enablers and successful strategies that have proven effective in expanding access to essential biotherapies.
- Analytical tools can be leveraged to identify inefficiencies and access gaps, thereby informing more strategic healthcare investments.
- Streamlining the development pathway for biosimilars can further stimulate competition across a wider spectrum of biological medicines.
- Impact of horizon scanning on the priorities of payers and regulatory agencies.
- Invaluable contributions of patients and healthcare professionals in driving the adoption of biosimilars across new and expanding therapy areas.
- Priority actions needed to pave the way for the introduction of Advanced Therapies biosimilars to the European market.
- Analyzing the global biotech ecosystem as it relates to biosimilar research and development, as well as manufacturing capabilities, with a specific focus on Europe’s competitive standing in this international landscape.
- And much much more...
WHO SHOULD ATTEND?
This Conference is designed for Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers working within:
- Follow on Biologics/Biosimilar
- Biologics/Biotechnology/ Biogenerics
- Biopharmaceuticals/ Biotherapeutics
- Legal Affairs
- Pricing and Reimbursement
- Clinical Immunology
- Regulatory Compliance
- Research & Development
- Preclinical and Clinical Development
- New Product Development
- Quality Affairs/ Quality Control
- Principal Scientist
- Pharmacovigilance
- Chief Scientific Officer
- Drug Safety & Risk Management
- Process Control and Analytical Technologies
- Business Development
- Commercial Affairs
- Marketing & sales
- Intellectual Property
- Legislation and Policy Advice
- Business Development
- Licensing
- Manufacturing
- Bioequivalence
- Drug and Safety Assessment
- Market Strategy
- Regulatory Affairs
- Health Economics
Key Industry Expert Speakers
Matthew Turner
Managing Director, External Affairs Consulting, former Senior Director Government Affairs and Policy Biosimilars
Fresenius Kabi
Schedule
Content Rich Program Agenda! Featuring Keynote Presentations, Stream Sessions, Panel, and Round Table Discussions.
Andreas Seidl, Chief Scientific Officer, Formycon
LANDSCAPE & CURRENT TRENDS
- Innovation, collaboration, and regulatory agility are key factors in shaping the accessibility, affordability, and quality of biosimilar therapies.
- New development and commercial models that can help offset the impact of price declines and rising competition
- Emerging new ventures who are creating an impact on the global market with their latest innovations and technologies.
- Reducing barriers to market entry and promoting global access to biosimilar therapies.
- Why Post-marketing pharmacovigilance is needed for biosimilars?
Moderator:
Panelist:
- Innovation and Differentiation in the context of Biologics and Biosimilars
- Emerging trends in Discovery and Development
- Promises, pitfalls and potential
Anita Krishnan, AVP, Head of Analytical Sciences, Biosimilars, Biocon Biologics
- Current situation in biosimilar development
- Eligibility – when could a tailored approach be envisaged
- Streamlined approach – what would and would not be asked for
- Current Stakeholder Engagement Initiatives and how you could participate
René Anour, Chair, EMA BMWP & Senior Medical Assessor, AGES, Austria
- The 20-year Biosimilar Journey
- What have we learnt after 2 decades of biosimilar launches?
- Perspectives for the future
Caroline Boulliat, CEO & Founder, Genchrome Limited (Former Biosimilar Country Manager
Amgen– & Global Team Lead Biosimilar –Pfizer)
- An overview on data analytics and digitalization
- Discuss what are the challenges
- User cases that we have implemented
- What we could have inferred all along: taking a Bayesian view
- A more favourable “prior” than generally appreciated
- The power of “indirect evidence” and the confidence it provides
Empirically confirmed (updating the “posterior”): to date no surprises - Improved assay sensitivity and what it tells us looking back
- Where do we go from here: implications for streamlined biosimilar development
Uwe Gudat, Chief Medical Officer, Biocon Biologics Limited
REGULATORY AND CLINICAL DEVELOPMENT
- Poor sensitivity of Phase III endpoints ?: ACR 20/50/70 in the ARMADA trial (Humira®)
- Originator is a moving Target: Originator batches used as template for designing cQAs sometimes do not match with batches, used as reference in biosimilar PhIII trials
- The needle in the haystack – clinical data as surrogate for critical quality attributes, not appropriately tested in the comparability exercise ?
- Comparability for hypothetical modes of action – Limits of operational feasibility ?
- Extrapolation of bioequivalence from healthy volunteers to patients ?: Addressing target mediated/time-dependent clearance ?
- Potential impact of alternative formulations and new materials, encountering drug product, on immunogenicity ?
- Clinician’s perception of biosimilars, approved without PhIII clinical testing: Deja-vu of the experiences made with the extrapolation exercise ?
Dr. Bernd Liedert, BL Consulting, formerly PEI/EMA, Merck KGaA, Boehringer Ingelheim,
Sandoz/Hexal
- Navigating phase 3 development in emerging countries
- Managing speed vs cost
- Some lessons learned
Chris Bell, Executive Director, Worldwide Clinical Trials
- CETs add significant cost and delay to the development of biosimilars, the time is ripe to re-examine their need
- This presentation examines the need for CETs focussing on anti-TNF biosimilars.
- Structural differences between biosimilars and reference products are detectable at levels well below those that could impact clinical outcomes
- In vitro potency testing is fully capable of revealing clinically relevant differences without need for CETs.
- Pharmacokinetic (PK) studies robustly address potential concerns relating to PK and immunogenicity
Cecil Nick, Vice President (Technical), PAREXEL
- For biologics/biosimilars, Analytical Characterization and particularly product-specific Critical Quality Attributes have long been considered as the α and ω of biosimilarity assessment.
- Recent experience (CSPC and others) have showed that some observed differences between reference product and biosimilars on some analytical parameters (e.g. glycosylation) do not have clinical consequences (efficacy, safety,PK).
- Hence, in this context, the notion of “Totality of Evidence “, used by most key-Agencies seems to represent the most relevant approach.
Xavier Frapaise, Principal, F.X. Frapaise Pharma Consulting
- Challenges and obstacles faced by manufacturers in developing biosimilars
- How to overcome challenges, increase development success and optimize result
- Techniques in bringing the next generation of Biosimilars to the market
- Reducing capital investment and creating cost effective and scalable manufacturing operations
Moderator:
Panellist:
Niloofa Tabarra, Medical Liaison Dermatology Lead (Biosimilars), Amgen
PATIENT ACCESS AND AFFORDABILITY
- Understanding biologics and their market potential
- Developing a comprehensive go-to-market strategy
- Regulatory considerations for biologics
- Pricing and reimbursement strategies
Moderator:
Panelist:
- Opportunities, threats and policy changes that impact the UK market
- Moving from transactional to strategic approach is needed
- Dedicated Biosimilar strategy required
- Scaling up the relationship between Government And Industry
Mark Samuels, CEO, Medicines UK, CEO, British Biosimilars Association
- Biologics had contributed to improving clinical outcomes across wide range of disease
- Access to Biologics is still suboptimal in terms of overall access % and time of initiation
- Biosimilars should be further leveraged to address these major access gaps and not just to help saving health care spending
- Treatment guidelines should further emphasise the role of biosimilars and position them as first line Biologics to help maximising treatment outcomes.
Dr. Mourad F. Rezk, VP, Global Head, Medical & Development, Biogen
- Efficient pathways for biosimilar approval while maintaining rigorous standards for safety and efficacy.
- Fostering healthy market competition for biosimilars is vital to ensure affordability and wider access for patients
- The significant role of patients and healthcare professionals in driving biosimilar adoption.
Niloofa Tabarra, Medical Liaison Dermatology Lead (Biosimilars), Amgen
- A Discussion debate
Dr Jeremy Morais, Medical Director UK, Ireland & Nordics, Fresenius Kabi Ltd
Dr. Mourad F. Rezk, VP, Global Head, Medical & Development, Biogen
- An holistic viewpoint of the current state of biosimilar policy covering regulatory, market access and
intellectual property illustrating areas that require evolving to fully harness the value of biosimilars
globally for healthcare systems, patients and industry alike
Matthew Turner, Managing Director, External Affairs Consulting, former Senior Director
Government Affairs and Policy Biosimilars, Fresenius Kabi
- Easy market access. All biosimilars enters the hospital market Day One after patent expiryHigh uptake. Within a few weeks they have a market share of 90+%
- Increased patient care. Many more patients are now treated with biologic medicine – often 200+%
- Sustainable health care budgets. Hugh savings – close to 10% of the total medicines budget for just a few products
Peter Jørgensen, CEO, The Danish Generic & Biosimilar Medicines Association
- Impact of the U.S Biosecure Act and it’s future
- Impact of the U.S PILLS Act on Generic drugs industry
- How would the U.S policy on Most favoured nation status for drug pricing play out?
- Priorities for the new US FDA and its impact on drug development & market access
Bobby George, VP, Group Head Regulatory Affairs, Reliance Life Sciences
- Biosimilars have the potential to significantly reduce the cost of biologic medications, improving affordability and accessibility for patients.
- Increased competition in the biologics market, facilitated by biosimilars, can lead to greater access to essential medications for a wider range of patients.
- Biosimilars can contribute to improved health outcomes for individuals with chronic and life- threatening diseases.
Kalveer Flora, Pharmacy Lead, Rheumatology, London North West Healthcare NHS Trust
- Strategies for overcoming barriers to biosimilar adoption
- How can biosimilar developers, patients, healthcare professionals and payers conspire to establish a sustainable market
- Importance of Physician and Patients input in shaping international standards for biosimilars
- Policies in place to encourage physicians / pharmacist collaboration
- Commercial potential and best ways on how to gauge such an opportunity in biosimilar
Moderator:
Panelist:
Dr. Mourad F. Rezk, VP, Global Head, Medical & Development, Biogen
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